LSK · Dna-Reagents, Chlamydia
Microbiology · 21 CFR 866.3120 · Class 1
Overview
| Product Code | LSK |
|---|---|
| Device Name | Dna-Reagents, Chlamydia |
| Regulation | 21 CFR 866.3120 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).
Classification Rationale
Class I (general controls).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 | Abbott Molecular, Inc. | May 28, 2010 | SESE |
| K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | Digene Corp. | Sep 25, 2001 | SESE |
| K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 | Digene Corp. | Sep 24, 2001 | SESE |
| K990023 | HYBRID CAPTURE II CT-ID TEST | Digene Corp. | Oct 25, 1999 | SESE |
| K920302 | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY | Gen-Probe, Inc. | Apr 6, 1994 | SESE |
| K920378 | PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | Apr 29, 1992 | SESE |
| K874878 | GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | Dec 29, 1987 | SESE |
| K871878 | RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | Oct 28, 1987 | SESE |
Top Applicants
- Gen-Probe, Inc. — 4 clearances
- Digene Corp. — 3 clearances
- Abbott Molecular, Inc. — 1 clearance
